Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2025 to 31 December 2025 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council)
Date: 2026-01-30
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: EU Member State, drug surveillance, market approval, marketing standard, medicinal product, veterinary medicinal product, withdrawal from the market








C_202600402EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2026/402


30.1.2026






Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 December 2025 to 31 December 2025
         


(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council
                (1)
or Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council
                (2)
)


(C/2026/402)

—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




22.12.2025


WAYRILZ


rilzabrutinib







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/25/1974


Film-coated tablet


Pending


23.12.2025




—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




4.12.2025


alli







Haleon Ireland Dungarvan Limited




Knockbrack,Dungarvan, Co. Waterford, Ireland






EU/1/07/401


5.12.2025




4.12.2025


AQUIPTA







AbbVie Deutschland GmbH & Co. KG




Knollstrasse, 67061 Ludwigshafen, Deutschland






EU/1/23/1750


5.12.2025




4.12.2025


Beovu







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/19/1417


5.12.2025




4.12.2025


Colobreathe







Essential Pharma Limited




Vision Exchange Building, Triq it-Territorjals, Zone 1, Central Business District, Birkirkara CBD 1070, Malta






EU/1/11/747


17.12.2025




4.12.2025


Gazyvaro







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/14/937


5.12.2025




4.12.2025


Ibandronic acid Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España






EU/1/12/798


5.12.2025




4.12.2025


Lenalidomide Krka







KRKA, d.d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/20/1519


5.12.2025




4.12.2025


NULIBRY







TMC Pharma (EU) Limited




7a Durands Court, 45 Parnell Street, Waterford, Co. Waterford, X91 P381, Ireland






EU/1/22/1684


5.12.2025




4.12.2025


Rivastigmine Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/09/599


9.12.2025




4.12.2025


Ronapreve







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/21/1601


5.12.2025




4.12.2025


Tauvid







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/24/1799


8.12.2025




4.12.2025


Triumeq







ViiV Healthcare BV




Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland






EU/1/14/940


9.12.2025




4.12.2025


Xolair







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/05/319


5.12.2025




5.12.2025


Aimovig







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/18/1293


8.12.2025




5.12.2025


Lyvdelzi







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/24/1898


8.12.2025




5.12.2025


Palforzia







STALLERGENES




6 rue Alexis de Tocqueville, 92160 Antony, France






EU/1/20/1495


15.12.2025




5.12.2025


Pregabalin Sandoz







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/15/1011


9.12.2025




5.12.2025


Soliris







Alexion Europe SAS




103-105 rue Anatole France, 92300 Levallois-Perret, France






EU/1/07/393


8.12.2025




8.12.2025


AUGTYRO







Bristol Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland






EU/1/24/1883


11.12.2025




12.12.2025


ABSIMKY







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España






EU/1/24/1880


15.12.2025




12.12.2025


ALTUVOCT







Swedish Orphan Biovitrum AB (publ)




112 76 Stockholm, Sverige






EU/1/24/1824


15.12.2025




12.12.2025


Arsenic Trioxide Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España






EU/1/19/1398


15.12.2025




12.12.2025


Biktarvy







Gilead Sciences Ireland UC




Carrigtohill, County Cork, T45 DP77, Ireland






EU/1/18/1289


17.12.2025




12.12.2025


Cystadane







Recordati Rare Diseases




Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France






EU/1/06/379


15.12.2025




12.12.2025


DuoTrav







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/06/338


15.12.2025




12.12.2025


Enurev Breezhaler







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/12/789


15.12.2025




12.12.2025


Exelon







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/98/066


15.12.2025




12.12.2025


Naglazyme







BioMarin International Limited




Shanbally, Ringaskiddy, County Cork P43 R298, Ireland






EU/1/05/324


16.12.2025




12.12.2025


Onbrez Breezhaler







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/09/593


15.12.2025




12.12.2025


Qaialdo







Lipomed GmbH




Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland






EU/1/23/1731


16.12.2025




12.12.2025


Retsevmo







Eli Lilly Nederland B.V.




Papendorpseweg 83, 3528 BJ Utrecht, Nederland






EU/1/20/1527


15.12.2025




12.12.2025


Saphnelo







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/21/1623


15.12.2025




12.12.2025


Seffalair Spiromax







Teva B.V.




Swensweg 5, 2031 GA Haarlem, Nederland






EU/1/21/1533


18.12.2025




12.12.2025


Voydeya







Alexion Europe SAS




103-105 rue Anatole France, 92300 Levallois-Perret, France






EU/1/24/1792


15.12.2025




15.12.2025


Lynparza







AstraZeneca AB




151 85 Södertälje, Sverige






EU/1/14/959


16.12.2025




15.12.2025


Minjuvi







Incyte Biosciences Distribution B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/21/1570


16.12.2025




15.12.2025


Vedrop







Recordati Rare Diseases




Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France






EU/1/09/533


17.12.2025




15.12.2025


Yesafili







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/23/1751


16.12.2025




16.12.2025


Hefiya







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/18/1287


17.12.2025




18.12.2025


Abiraterone Krka







KRKA d d., Novo mesto




Šmarješka cesta 6, 8501 Novo mesto, Slovenija






EU/1/21/1553


5.1.2026




18.12.2025


Afqlir







Sandoz GmbH




Biochemiestrasse 10, 6250 Kundl, Österreich






EU/1/24/1867


22.12.2025




18.12.2025


Alymsys







Mabxience Research SL




C/ Manuel Pombo Angulo 28, 28050 Madrid, España






EU/1/20/1509


20.12.2025




18.12.2025


Amsparity







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/19/1415


19.12.2025




18.12.2025


Avastin







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/04/300


19.12.2025




18.12.2025


Avzivi







FGK Representative Service GmbH




Heimeranstrasse 35, 80339 München, Deutschland






EU/1/24/1834


19.12.2025




18.12.2025


Aybintio







Samsung Bioepis NL B.V.




Olof Palmestraat 10, 2616 LR Delft, Nederland






EU/1/20/1454


22.12.2025




18.12.2025


Farydak







pharmaand GmbH




Taborstrasse 1, 1020 Wien, Österreich






EU/1/15/1023


19.12.2025




18.12.2025


Inrebic







Bristol-Myers Squibb Pharma EEIG




Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland






EU/1/20/1514


19.12.2025




18.12.2025


Lyxumia







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/12/811


19.12.2025




18.12.2025


M-M-RVAXPRO







Merck Sharp & Dohme B.V.




Waarderweg 39, 2031 BN Haarlem, Nederland






EU/1/06/337


19.12.2025




18.12.2025


Nexium Control







Haleon Ireland Dungarvan Limited




Knockbrack,Dungarvan, Co. Waterford, Ireland






EU/1/13/860


19.12.2025




18.12.2025


Oyavas







STADA Arzneimittel AG




Stadastraße 2-18, 61118 Bad Vilbel, Deutschland






EU/1/20/1510


19.12.2025




18.12.2025


Pedea







Recordati Rare Diseases




Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France






EU/1/04/284


19.12.2025




18.12.2025


Rivastigmine 1 A Pharma







1 A Pharma GmbH




Industriestraße 18, 83607 Holzkirchen, Deutschland






EU/1/09/585


19.12.2025




18.12.2025


Shingrix







GlaxoSmithKline Biologicals S.A.




rue de l'Institut 89, 1330 Rixensart, Belgique






EU/1/18/1272


19.12.2025




18.12.2025


Tremfya







Janssen-Cilag International NV




Turnhoutseweg 30, 2340 Beerse, België






EU/1/17/1234


19.12.2025




18.12.2025


Vegzelma







Celltrion Healthcare Hungary Kft.




Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország






EU/1/22/1667


22.12.2025




18.12.2025


VEYVONDI







Baxalta Innovations GmbH




Industriestraße 67, 1221 Wien, Österreich






EU/1/18/1298


19.12.2025




18.12.2025


Vyloy







Astellas Pharma Europe B.V.




Sylviusweg 62, 2333 BE Leiden, Nederland






EU/1/24/1856


19.12.2025




18.12.2025


XALKORI







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/12/793


19.12.2025




18.12.2025


Xerava







PAION Pharma GmbH




Heussstraße 25, 52078 Aachen, Deutschland






EU/1/18/1312


24.12.2025




18.12.2025


Zirabev







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/18/1344


19.12.2025




19.12.2025


Abevmy







Biosimilar Collaborations Ireland Limited




Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland






EU/1/20/1515


23.12.2025




19.12.2025


Abiraterone Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España






EU/1/20/1512


22.12.2025




19.12.2025


Aldurazyme







Sanofi B.V.




Paasheuvelweg 25, 1105 BP Amsterdam, Nederland






EU/1/03/253


22.12.2025




19.12.2025


Kevzara







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/17/1196


22.12.2025




19.12.2025


Kisqali







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/17/1221


22.12.2025




19.12.2025


Levetiracetam Accord







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España






EU/1/11/712


22.12.2025




19.12.2025


Mayzent







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/19/1414


26.12.2025




19.12.2025


Mirvaso







Galderma International




Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France






EU/1/13/904


22.12.2025




19.12.2025


Mvasi







Amgen Technology (Ireland) UC




Pottery Road, Dun Laoghaire, Co. Dublin, Ireland






EU/1/17/1246


23.12.2025




19.12.2025


PHEBURANE







Eurocept International BV




Trapgans 5, 1244 RL Ankeveen, Nederland






EU/1/13/822


23.12.2025




19.12.2025


Qdenga







Takeda Pharmaceuticals International AG




Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Co. Dublin, D02 HW68, Ireland






EU/1/22/1699


29.12.2025




19.12.2025


Seebri Breezhaler







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/12/788


22.12.2025




19.12.2025


Teriparatide SUN







Sun Pharmaceutical Industries Europe B.V.




Polarisavenue 87, 2132JH Hoofddorp, Nederland






EU/1/22/1697


5.1.2026




19.12.2025


Topotecan Hospira







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/10/633


22.12.2025




19.12.2025


Voriconazole Hikma







Hikma Farmacêutica (Portugal), S.A.




Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal






EU/1/15/1004


22.12.2025




19.12.2025


Votrient







Novartis Europharm Limited




Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland






EU/1/10/628


22.12.2025




—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)









Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




4.12.2025


Granupas







Eurocept International B.V.




Trapgans 5, 1244 RL Ankeveen, Nederland






EU/1/13/896


10.12.2025




5.12.2025


Ronapreve







Roche Registration GmbH




Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland






EU/1/21/1601


8.12.2025




15.12.2025


ABSIMKY







Accord Healthcare S.L.U.




World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España






EU/1/24/1880


16.12.2025




18.12.2025


Lyxumia







Sanofi Winthrop Industrie




82 avenue Raspail, 94250 Gentilly, France






EU/1/12/811


19.12.2025




18.12.2025


Mimpara







Amgen Europe B.V.




Minervum 7061, 4817 ZK Breda, Nederland






EU/1/04/292


7.1.2026




19.12.2025


Copiktra







Secura Bio Limited




32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland






EU/1/21/1542


5.1.2026




—   Suspension of a marketing authorisation (Article 20 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)









Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




9.12.2025


Oxbryta







Pfizer Europe MA EEIG




Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België






EU/1/21/1622


10.12.2025




—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




4.12.2025


Vaxxinact H5


Avian influenza vaccine (subunit recombinant)







Boehringer Ingelheim Vetmedica GmbH




55216 Ingelheim am Rhein, Deutschland






EU/2/25/356


Emulsion for injection


QI01AA23


8.12.2025




18.12.2025


ECOVAXXIN MS


Mycoplasma synoviae vaccine (live)







Eco Animal Health Europe Ltd




6th Floor, South Bank House, Barrow Street, Dublin 4 D04 TR29, Ireland






EU/2/25/357


Eye drops, suspension


QI01AE03


22.12.2025




—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council; Article 5 of Regulation (EU) 2019/6 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




18.12.2025


AdTab







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/22/288


22.12.2025




18.12.2025


Credelio Plus







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/21/271


22.12.2025




18.12.2025


Enteroporc Coli AC







Ceva Santé Animale




10 avenue de La Ballastière, 33500 Libourne, France






EU/2/20/262


19.12.2025




18.12.2025


FRONTPRO







Boehringer Ingelheim Vetmedica GmbH




D-55216 Ingelheim am Rhein, Deutschland






EU/2/19/240


19.12.2025




18.12.2025


Kriptazen







Virbac




1ère Avenue – 2065 m – L.I.D., 06516 Carros CEDEX, France






EU/2/18/234


22.12.2025




18.12.2025


Librela







Zoetis Belgium




rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique






EU/2/20/261


19.12.2025




18.12.2025


Lotimax







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/24/311


22.12.2025




18.12.2025


Melosus







CP-Pharma Handelsgesellschaft mbH




Ostlandring 13, 31303 Burgdorf, Deutschland






EU/2/10/116


22.12.2025




18.12.2025


YURVAC RHD







Laboratorios Hipra, S.A.




Avda. La Selva, 135, 17170 Amer (Girona), España






EU/2/23/298


23.12.2025




18.12.2025


Zenalpha







Vetcare Oy




P.O. Box 99, 24101 Salo, Suomi






EU/2/21/279


19.12.2025




22.12.2025


Credelio







Elanco GmbH




Heinz-Lohmann-Straße 4, 27472 Cuxhaven, Deutschland






EU/2/17/206


5.1.2026




22.12.2025


Vectormune FP ILT + AE







Ceva-Phylaxia Co. Ltd.




Szállás u. 5, 1107 Budapest, Magyarország






EU/2/20/250


1.1.2026




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





European Medicines Agency




Domenico Scarlattilaan 6




1083 HS Amsterdam




NETHERLANDS






(1)  
            OJ L 136, 30.4.2004, p. 1, ELI: https://data.europa.eu/eli/reg/2004/726/oj.

(2)  
            OJ L 4, 7.1.2019, p. 43, ELI: https://data.europa.eu/eli/reg/2019/6/oj.


ELI: http://data.europa.eu/eli/C/2026/402/oj
ISSN 1977-091X (electronic edition)